Phase 4
N=96
Dosage of Epidural Morphine in Elderly Patients
Age Problem · Abdominal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04316871 ↗Enrolled (actual)
96
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption. — 27.182; 9.182; 6.273; 38.136 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 1.5 mg of Morphine Sulfate (Drug); Normal saline (Drug); 3 mg of Morphine Sulfate (Drug); 4.5 mg of Morphine Sulfate (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Assiut University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption. |
27.182; 9.182; 6.273; 38.136 | — |
| SECONDARY Visual Analog Scale |
3.95; 2.00; 1.68; 4.32 | — |
| SECONDARY Modified Ramsay Sedation Scale |
1.95; 2.18; 3.05; 1.86 | — |
| SECONDARY Nausea Score |
4.41; 4.45; 4.59; 4.82 | — |
| SECONDARY Vomiting Score |
3.18; 3.00; 3.86; 1.45 | — |
| SECONDARY Pruritus Score |
3.36; 3.68; 3.23; 1.91 | — |
Summary
This a clinical trial that evaluates the efficacy and safety of three different doses of morphine, namely 1.5 mg, 3 mg and 4.5 mg, via the epidural route regarding reducing pain in elderly patients after a cancer surgery in the lower abdomen
Eligibility Criteria
Inclusion Criteria
- Men and women aged ≥ 60 years, who are planned to undergo lower abdominal cancer surgery.
2- ASA I and II classifications. 2. Surgeries via infra-umbilical abdominal incision is considered eligible.
Exclusion Criteria
- Patient refusal.
- Patients who are morbidly obese (body mass index ≥ 40 kg/m2).
- Those with contraindications to neuraxial analgesia. 4- psychiatric illness that would interfere with the perception and the assessment of pain.
Data sourced from ClinicalTrials.gov (NCT04316871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.